Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-07 @ 11:11 PM
Study NCT ID:
NCT02010333
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019905', 'term': 'Benzyl Alcohol'}], 'ancestors': [{'id': 'D001592', 'term': 'Benzyl Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001593', 'term': 'Benzyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2015-08-25', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2013-12-09', 'dispFirstSubmitQcDate': '2015-09-09', 'studyFirstSubmitQcDate': '2013-12-09', 'dispFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of Ha44 Gel', 'timeFrame': '8 months', 'description': 'Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.'}]}, 'conditionsModule': {'conditions': ['Head Lice Infestation']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 6months \\< 3years of age\n2. Good health\n3. Active head lice infestation defined as the presence of at least 3 live lice\n4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)\n5. Parent/guardian agrees to allow PK samples collected\n6. Signed Informed Consent Form\n\nExclusion Criteria:\n\n1. Condition or illness that in the opinion of the investigator may interfere with the study results.\n2. Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.\n3. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.\n4. Receiving systemic or topical medication that may interfere the study results.\n5. Received an investigational agent within 30 days prior to Day 0.'}, 'identificationModule': {'nctId': 'NCT02010333', 'briefTitle': 'A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation', 'organization': {'class': 'INDUSTRY', 'fullName': "Dr. Reddy's Laboratories Limited"}, 'officialTitle': 'A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation', 'orgStudyIdInfo': {'id': 'Ha03-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ha44 Gel 0.74% w/w', 'description': 'Open label, one arm', 'interventionNames': ['Drug: Ha44 Gel 0.74% w/w']}], 'interventions': [{'name': 'Ha44 Gel 0.74% w/w', 'type': 'DRUG', 'otherNames': ['Abametapir 0.74%', 'Benzyl Alcohol'], 'description': 'HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.', 'armGroupLabels': ['Ha44 Gel 0.74% w/w']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93618', 'city': 'Dinuba', 'state': 'California', 'country': 'United States', 'facility': 'Universal Biopharma Research Institute', 'geoPoint': {'lat': 36.54328, 'lon': -119.38707}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Reddy's Laboratories Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}